Status:
COMPLETED
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Spanish Society of Cardiology
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigate...
Detailed Description
Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they re...
Eligibility Criteria
Inclusion
- Symptomatic recurrent paroxysmal AF (\>2 episodes in the last 6 months), and
- Refractory to one or more class I or III antiarrhythmic drugs, and
- PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.
Exclusion
- Age: \< 18 or \> 75 year-old
- Prior AF ablation
- Pregnancy
- Concomitant acute illness
- Hyperthyroidism
- Moderate to severe valvular heart disease
- Prior cardiac surgery
- Left atrium \> 50 mm (anteroposterior diameter, parasternal long-axis view)
- Intracardiac thrombus
- Contraindications for anticoagulant therapy
- Inability to be followed in our center for at least 1 year
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00969735
Start Date
July 1 2009
End Date
May 1 2012
Last Update
April 4 2013
Active Locations (1)
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1
Unidad de Arritmias, Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040